Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Patients were recruited from study sites in the United States and Argentina. There were 10 patients from Argentina.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Ranibizumab 0.3 mg

Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.

Ranibizumab 0.5 mg

Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.

Sham Injection/Ranibizumab 0.5 mg

Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.

Participant Flow for 3 periods

Period 1: Core Study

Ranibizumab 0.3 mg

Ranibizumab 0.5 mg

Sham Injection/Ranibizumab 0.5 mg

STARTED

125

125

127

COMPLETED

98

100

86

NOT COMPLETED

27

25

41

Adverse Event

4

4

1

Death

6

4

4

Lost to Follow-up

5

5

10

Physician Decision

2

1

3

Subject Non-compliance

1

2

1

Subject Required Other Therapy

0

1

3

Subject's Decision

9

8

19

Period 2: Open-label Extension Through Month 48

Ranibizumab 0.3 mg

Ranibizumab 0.5 mg

Sham Injection/Ranibizumab 0.5 mg

STARTED

89 [1]

79 [1]

77 [1]

COMPLETED

63

59

50

NOT COMPLETED

26

20

27

Adverse Event

0

0

2

Death

2

0

0

Lost to Follow-up

1

0

2

Physician's Decision

2

1

3

Subject's Decision

1

3

3

Sponsor’s Decision to Terminate Study

18

15

16

Subject Non-compliance

2

1

0

Subject Required Other Therapy

0

0

1

[1]

Not all participants who completed the core study entered the optional open-label extension.

Period 3: Open-label Extension Through Month 60

Ranibizumab 0.3 mg

Ranibizumab 0.5 mg

Sham Injection/Ranibizumab 0.5 mg

STARTED

89 [1]

79 [1]

77 [1]

COMPLETED

1

1

0

NOT COMPLETED

88

78

77

Adverse Event

0

0

2

Death

2

2

1

Lost to Follow-up

3

0

4

Physician's Decision

2

1

3

Subject's Decision

1

3

4

Sponsor’s Decision to Terminate Study

77

71

62

Subject Non-compliance

2

1

0

Subject Required Other Therapy

1

0

1

[1]

Not all participants who completed the core study entered the optional open-label extension.